Food Safety Magazine, October/November 2008

FOCUS ON GMPs
By Ken Gall
Good Manufacturing
Practices and Training

Good manufacturing practices (GMPs)
describe the conditions and practices
that are necessary for the manufactur-
ing, processing, packing or storage of
food to ensure its safety and whole-
someness. The current GMPs com-
prise the basis for determining whether the practices, conditions and
controls used to process, handle or store food products are safe and
whether the conditions in the facility are sanitary.

The current federal GMP regulation specifically applies to all food products regulated by FDA. This regulation can be found in Part 110 of Title 21 of the Code of

Federal Regulations. It outlines the basic sanitary controls that are required for all food processing plants, wholesale or food distribution firms and food storage facilities that handle, store or process FDA-regulated food. This GMP regulation also provides a framework for the specific state regulations that may apply to these firms, and for the specific regulations for animal foods that are regulated by the USDA.

Table 1 shows an overview of FDA’s GMP regulation to illustrate how it is organized and what it covers. It is divided into 7 subparts, and each subpart includes various sections that are identified with a series of numbers that start with the symbol § and the number 110. The specific topics covered in each of these sections of the GMP regulation are then listed.

The GMP regulations are designed to be the “minimum” standards for the food industry. Because the GMP regulation is general in nature, it uses words such as “adequate,” “appropriate” or “as necessary.” Each firm must develop and implement procedures for each GMP requirement that will protect the food that they receive, store or process from contamination. These procedures are specific to each firm since they are